2 Clinical Research Associate Pharmaceutical Development jobs in whatjobs
Clinical Research Associate - Pharmaceutical Development
Posted 7 days ago
Job Viewed
Job Description
Our client, a leading pharmaceutical company, is seeking a dedicated and meticulous Clinical Research Associate (CRA) to join our innovative, fully remote team. This position is vital to the successful execution of clinical trials, ensuring adherence to protocols, regulations, and ethical standards. As a remote-first role, you will have the flexibility to manage your responsibilities from anywhere, contributing to groundbreaking pharmaceutical research. You will be responsible for monitoring clinical trial sites, ensuring data integrity, and verifying patient safety. The ideal candidate has a solid understanding of Good Clinical Practice (GCP) guidelines and regulatory requirements. Responsibilities include initiating, monitoring, and closing out clinical study sites, conducting source data verification, resolving data queries, and ensuring timely reporting of adverse events. You will also serve as a key liaison between the sponsor, investigators, and study staff. Strong organizational skills, excellent attention to detail, and the ability to work independently are essential. This role requires effective communication and interpersonal skills to build strong relationships with site personnel. The opportunity to contribute to the development of life-saving medications is significant. This is a remote position, with the **Nyeri, Nyeri, KE** location serving as the administrative base. Our client is committed to supporting its remote workforce and ensuring high standards of operational excellence.
Key Responsibilities:
Key Responsibilities:
- Initiate, monitor, and close-out clinical investigator sites.
- Ensure clinical trials are conducted, recorded, and reported in accordance with protocol, standard operating procedures (SOPs), and applicable regulations.
- Verify the accuracy and completeness of clinical trial data through source data verification.
- Ensure patient safety and rights are protected.
- Manage and resolve data queries in collaboration with investigators and study staff.
- Train and provide ongoing support to site staff.
- Oversee regulatory compliance at study sites.
- Prepare and present monitoring visit reports.
- Liaise effectively between the sponsor, investigators, and other stakeholders.
- Ensure timely submission of study-related documents.
- Proven experience as a Clinical Research Associate (CRA) or similar role in clinical research.
- In-depth knowledge of GCP guidelines, ICH regulations, and local regulatory requirements.
- Experience in site monitoring, data verification, and query resolution.
- Strong understanding of clinical trial processes and documentation.
- Excellent organizational and time management skills.
- Exceptional attention to detail and accuracy.
- Strong written and verbal communication skills.
- Ability to work independently and travel as needed (though the role is primarily remote).
- Bachelor's degree in a life science, nursing, or related field.
This advertiser has chosen not to accept applicants from your region.
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Clinical Research Associate - Pharmaceutical Development
Posted 18 days ago
Job Viewed
Job Description
Our client, a leading innovator in pharmaceutical research, is seeking a dedicated and detail-oriented Clinical Research Associate (CRA) to join their esteemed, fully remote clinical development team. This crucial role involves overseeing and managing clinical trial activities, ensuring compliance with regulatory standards, and safeguarding the integrity of data collected. The CRA will be responsible for site selection, initiation, monitoring, and close-out activities, acting as a vital liaison between the sponsor and investigational sites. This position requires a strong understanding of Good Clinical Practice (GCP) guidelines, clinical trial protocols, and pharmaceutical research methodologies.
Responsibilities:
Qualifications:
Responsibilities:
- Conduct site visits (remote and/or on-site as required, with travel as needed) to assess protocol and regulatory compliance, data accuracy, and overall site performance.
- Ensure that investigational sites adhere strictly to the study protocol, GCP, and all applicable regulatory requirements.
- Manage communication with clinical investigators and site staff, providing necessary training and ongoing support.
- Review and verify source documents, case report forms (CRFs), and other study-related records for accuracy and completeness.
- Identify, document, and resolve deviations and adverse events promptly and appropriately.
- Assist in the preparation and distribution of study-related documents and essential regulatory documents.
- Track study progress, identify potential risks, and implement mitigation strategies to ensure timely completion of study milestones.
- Participate in investigator meetings and training sessions as required.
- Contribute to the development and refinement of study protocols and clinical research processes.
Qualifications:
- A Bachelor's degree in a life science, nursing, pharmacy, or a related healthcare field. Advanced degree preferred.
- Minimum of 3-5 years of direct experience as a CRA in the pharmaceutical or biotechnology industry.
- Thorough knowledge of GCP, ICH guidelines, FDA regulations, and other relevant regulatory standards.
- Experience in monitoring various phases of clinical trials.
- Excellent organizational skills, with the ability to manage multiple priorities and deadlines effectively.
- Strong written and verbal communication skills, with the ability to document findings clearly and concisely.
- Proficiency in clinical trial management systems (CTMS) and electronic data capture (EDC) systems.
- Ability to work independently and collaboratively in a remote team environment.
- This role supports global initiatives but is specifically aligned with operational oversight relevant to the Eldoret, Uasin Gishu, KE geographical area, requiring adherence to local regulatory nuances.
This advertiser has chosen not to accept applicants from your region.
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